80K/RAPIDO Cable 1600929-001

GUDID 17630055508048

Bien-Air Surgery SA

Electrical-only medical device connection cable, reusable

• Primary Device ID: 17630055508048
• NIH Device Record Key: fbe1d829-4329-4ef2-8bff-8637e1dbe5da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 80K/RAPIDO Cable
• Version Model Number: 1600929
• Catalog Number: 1600929-001
• Company DUNS: 481597719
• Company Name: Bien-Air Surgery SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055508041 [Primary]
GS1	17630055508048 [Package]; Contains: 07630055508041; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• NLY: Microdebrider, Ent, High Speed, Single Use, Reprocessed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-10
• Device Publish Date: 2023-01-30

Devices Manufactured by Bien-Air Surgery SA

• 17630055513042 - Bur PM2-70 80K steel Ø3.5x80 sterile: 2026-02-19
• 17630055513059 - Bur PM2-70 80K steel Ø4.0x80 sterile: 2026-02-19
• 17630055513073 - Bur PM2-70 80K steel Ø5.0x80 sterile: 2026-02-19
• 17630055513394 - Bur PM2-95 80K steel Ø2 sterile: 2026-02-19
• 17630055513417 - Bur PM2-95 80K steel Ø3 sterile: 2026-02-19
• 17630055513486 - Bur PM2-125 80K steel Ø1 sterile: 2026-02-19
• 17630055513509 - Bur PM2-125 80K steel Ø2 sterile: 2026-02-19
• 17630055513523 - Bur PM2-125 80K steel Ø3 sterile: 2026-02-19